MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-4-6-3D-SS
Medical Device Problem Codes	Separation Failure (2547); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that during coil embolization of aneurysm, after the coil body was completely filled, the detachment wire was pulled out to detach the coil, and the pusher rod was withdrawn to find that the coil body was pulled out, and it was suspected that the coil was not successfully detached.After repeated adjustments, the coil was finally detached, and the tail of the coil body could only remain in the blood vessel.Later, a stent was used to remedy the situation, pressing the free coil body against the blood vessel wall.There was non-detachment.The physician did not try to detach with another instant detacher.There was a manual attempt at detachment via hypotube.There was no issue with the instant detacher.The patient was undergoing surgery for treatment of a saccular, unruptured internal carotid artery (ica) aneurysm with a max diameter of 4 mm and a 3.2 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received reported they used manual detachment to detach.The coil was in the correct location after detaching.The coil moved after detaching.No instant detacher was used.2 attempts were made with the instant detacher.Prior to coil non-detachment no issues encountered.The damage to the pushwire was observed after removal from the patient.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21322187
• Report Number: 9617601-2025-00144
• Device Sequence Number: 8485378
• Product Code: KRD
• UDI-Device Identifier: 00847536008144
• UDI-Public: 00847536008144
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2026
• Device Model Number: APB-4-6-3D-SS
• Device Catalogue Number: APB-4-6-3D-SS
• Device Lot Number: 227440117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 02/08/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/25/2025
• Date Device Manufactured: 10/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male